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E-Line

FDA UDI

Class II (US FDA UDI)

by Richard Wolf GmbH

Identity

Trade Name
E-LINE FDA UDI
Generic Name
Endoscope sheath, reusable FDA UDI
Device Name
SHEATH FOR CYSTOSCOPE 19.5FR color code red, SL 209mm, oval, slanted distal end, capacity for instruments up to 7Fr or 2x 5Fr, compatible with attachments 8652254, 8652264, 8652.284, and telescopes Ø 4mm, with 2 flushing ports, quick-lock, reusable FDA UDI
Model / Reference
86520345 FDA UDI
Description
SHEATH FOR CYSTOSCOPE 19.5FR color code red, SL 209mm, oval, slanted distal end, capacity for instruments up to 7Fr or 2x 5Fr, compatible with attachments 8652254, 8652264, 8652.284, and telescopes Ø 4mm, with 2 flushing ports, quick-lock, reusable FDA UDI

Identifiers

Catalog Number
8652.0345 FDA UDI
Primary DI / UDI-DI
04055207027998 FDA UDI
FDA Product Code
FBO FDA UDI
GMDN Term
Endoscope sheath, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 6.5 Millimeter FDA UDI

E-Line by Richard Wolf GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Richard Wolf GmbH

Sources (1)

  • FDA UDI 6bda8d56-e66d-4eae-b712-e40d8b70e864 37 fields · synced Jun 8, 2026